WO2000066041A1 - Intraocular lenses - Google Patents

Intraocular lenses Download PDF

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Publication number
WO2000066041A1
WO2000066041A1 PCT/US2000/007698 US0007698W WO0066041A1 WO 2000066041 A1 WO2000066041 A1 WO 2000066041A1 US 0007698 W US0007698 W US 0007698W WO 0066041 A1 WO0066041 A1 WO 0066041A1
Authority
WO
WIPO (PCT)
Prior art keywords
eye
lens
intraocular lens
optical axis
optic portion
Prior art date
Application number
PCT/US2000/007698
Other languages
French (fr)
Inventor
Helene Lamielle
Laurent Hoffmann
Vincent Blanchard
Original Assignee
Bausch & Lomb Surgical, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Bausch & Lomb Surgical, Inc. filed Critical Bausch & Lomb Surgical, Inc.
Priority to BR0011218A priority Critical patent/BR0011218A/en
Priority to CA 2370859 priority patent/CA2370859C/en
Priority to AU39124/00A priority patent/AU775571B2/en
Priority to JP2000614928A priority patent/JP2002542885A/en
Priority to MXPA01010983A priority patent/MXPA01010983A/en
Priority to EP00918291A priority patent/EP1173114A1/en
Publication of WO2000066041A1 publication Critical patent/WO2000066041A1/en
Priority to HK02105266.4A priority patent/HK1045248A1/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/14Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • A61F2/16Intraocular lenses
    • A61F2/1613Intraocular lenses having special lens configurations, e.g. multipart lenses; having particular optical properties, e.g. pseudo-accommodative lenses, lenses having aberration corrections, diffractive lenses, lenses for variably absorbing electromagnetic radiation, lenses having variable focus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/14Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • A61F2/16Intraocular lenses
    • A61F2002/1681Intraocular lenses having supporting structure for lens, e.g. haptics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/14Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • A61F2/16Intraocular lenses
    • A61F2002/16965Lens includes ultraviolet absorber
    • A61F2002/1699Additional features not otherwise provided for

Definitions

  • the present invention relates to intraocular lenses (lOLs) and a
  • invention relates to lOLs designed primarily for refractive correction in aphakic
  • aphakic eyes to replace a surgically removed diseased natural lens, such as
  • IOL implants have been used for years in aphakic eyes as
  • haptics connected to and surrounding at least part of the
  • the haptic portions of an IOL are designed to support the optic
  • biocompatible materials ranging from more rigid materials such as
  • PMMA polymethylmethacrylate
  • Haptic portions of the lOLs have been formed separately from the optic
  • Such softer lOLs may be deformed prior to insertion thereof
  • the IOL returns to its original pre-deformed shape due to the memory
  • lens must be inserted through an incision in the cornea slightly larger than the
  • Compressive forces exerted on an IOL also tend to cause the lens to tilt or
  • Movement of an IOL along the optical axis of an eye has the potential to
  • IOL manufacturers provide a wide range of IOL sizes to more precisely fit
  • An intraocular lens (IOL) made in accordance with the present invention
  • invention has an optic portion with an outer peripheral edge and two looped
  • haptic elements for supporting the optic portion in a patient's eye.
  • subject IOL is balanced having one looped haptic element formed on one
  • Each of the looped haptic elements has two broad
  • each looped haptic element is connected to the outer peripheral
  • Each looped haptic element forms a large
  • haptic elements' spring portions and linking portions are designed to engage
  • Each looped haptic element's broad connecting portions are designed
  • each looped haptic element is
  • present IOL tends to have maximized stability within an eye.
  • intraocular lenses for use in aphakic eyes.
  • Another object of the present invention is to provide intraocular lenses
  • Another object of the present invention is to provide intraocular lenses
  • Another object of the present invention is to provide intraocular lenses
  • Still another object of the present invention is to provide intraocular
  • FIGURE 1 is a schematic representation of the interior of a human eye
  • FIGURE 2 is a plan view of an IOL with an optic and two looped haptic
  • FIGURE 3 is a side view of the IOL of Figure 2;
  • FIGURE 4 is a side view of the IOL of Figure 2 with sharper peripheral
  • FIGURE 5 is a side view of the IOL of Figure 2 with sharper edges on
  • FIGURE 6 is a side view of the IOL of Figure 2 with rounder edges on
  • FIGURE 7 is a side view of a looped haptic element of Figure 2 taken
  • Figure 1 illustrates a simplified diagram of an eye 10 showing landmark
  • Eye 10 includes an optically clear cornea 12 and an iris 14.
  • Eye 10 also includes anterior chamber 20 located in front of iris 14 and
  • posterior chamber 22 located between iris 14 and natural lens 16.
  • lOLs of the present invention are preferably implanted into lens capsule 24 or
  • Eye 10 also includes an optical
  • OA in the human eye 10 is generally perpendicular to a portion of cornea 12,
  • IOL 32 is designed for implantation
  • IOL 32 has an optic portion 34 with an outer peripheral edge 36.
  • peripheral edge 36 of optic portion 34 are two
  • linking portion 46 Broad connecting portions 40 are preferably integrally
  • looped haptic elements 38 may be
  • Looped haptic elements 38 are designed so that when IOL 32 is implanted in a patient's eye 10 and held in
  • haptic elements 38 flex to accommodate the particular size of eye 10.
  • Looped haptic elements 38 are designed to be resistent to flexing and tilting
  • IOL 32 may be manufactured in one or a few standard sizes and be a suitable
  • haptic elements 38 also minimize axial displacement of optic portion 34 in a
  • connecting portions 40 are designed to be broad to increase rigidity and to
  • Each broad connecting portion 40 preferably measures
  • Radial orientation portions 42 of looped haptic elements 38 have
  • Interior surfaces 54 and exterior surfaces 56 Interior surfaces 54 and exterior surfaces 56.
  • surfaces 56 are formed with an outward curve to increase the stability of IOL
  • surface area of outer ends 58 is designed to be as small as possible to
  • the width of outer ends 58 is also designed
  • Spring portions 44 have an interior surface 62 and an exterior surface
  • Spring portions 44 are designed to absorb compressive forces exerted by
  • interior surfaces 62 may abut outer ends 58. Also, when placed
  • each spring portion 44 may deflect
  • Linking portions 46 connect adjacent spring portions 44 to form a
  • Linking portions 46 are slightly bowed at
  • Fenestration 68 defined by interior surfaces 54 and 62, and interior
  • IOL 32 an approximately 2.0 mm in overall length compression of IOL 32, such as
  • IOL 32 achieves significantly minimized axial displacement or tilting
  • optic portion 34 to protect the eye 10 from damage when compressive
  • Another feature which may be incorporated into the subject lens is a
  • the subject IOL 32 is preferably produced having an optic portion 34
  • Looped haptic elements 38 increase or
  • looped haptic elements 38 are formed to be approximately 8.5 to
  • Looped haptic elements 38 have the same thickness thoughout their entire
  • portion 46 are approximately 0.4 to 1.5 mm, but preferably approximately 0.6
  • portions 42 are approximately 1.6 to 4.5 mm, but preferably approximately 2.0
  • IOL 32 may likewise be achieved or enhanced by incorporating a stiffening
  • element 82 in the shape of a ribbon, in looped haptic elements 38, as
  • Stiffening elements 82 may be positioned in looped
  • haptic elements 38 to function in a manner similar to that of an I-beam in
  • Stiffening elements 82 are formed of a less flexible material than that
  • Suitable materials for stiffening elements 82 include but are not
  • polyimides polyolefins, high-density polyethylenes, polyesters,
  • Stiffening elements 82 may be used in conjunction with
  • looped haptic design is desired while still achieving the desired flexibility
  • Suitable materials for the production of the subject IOL 32 include but
  • polymers hydrocarbon and fluorocarbon polymers, hydrogels, soft acrylic
  • hydrophilic monomer units fluorine-containing polysiloxane elastomers
  • the present invention is a hydrogel made from 2-hydroxyethyl methacrylate
  • HEMA 6-hydroxyhexyl methacrylate
  • HOHEXMA 6-hydroxyhexyl methacrylate
  • HOHEXMA Poly(HEMA-co-HOHEXMA) is the preferred material for the
  • refractive index is a desirable feature in the production of lOLs to impart high
  • optical power with a minimum of optic thickness By using a material with a high refractive index, visual acuity deficiencies may be corrected using a
  • lOLs is undesirable due to potential damage to delicate tissues within the eye.
  • Poly(HEMA-co-HOHEXMA) also has dimensional stability in the eye.
  • PMMA polymethyl methacrylate
  • Optic portion 34 of IOL 32 can be a positive powered lens from 0 to
  • Optic portion 34 may be biconvex, plano ⁇
  • Optic portion 34 of the subject IOL 32 may optionally be formed with a
  • glare reduction zone 84 of approximately 0.25 to 0.75 mm but more
  • edge 36 of IOL 32 is struck by light entering eye10 during high light or at
  • Glare reduction zone 84 is typically
  • optic portion 34 fabricated of the same material as optic portion 34, but may be opaque,
  • Subject IOL 32 is preferably manufactured by first producing discs from
  • IOL 32 may
  • IOL 32 may be polished, cleaned, sterilized and packaged by a
  • Subject IOL 32 is used in eye 10 by creating an incision in cornea 12,
  • IOL 32 may be used in eye 10 by creating an incision in cornea
  • IOL 32 of the present invention provides for a refractive lens suitable
  • IOL 32 has looped haptic elements 38 with flexibility characteristics that minimize axial displacement or
  • IOL 32 distortion of vision and damage to delicate tissues within eye 10.

Abstract

A refractive intraocular lens (32) including an optic portion (34) having an outer peripheral edge (36) and two opposed looped haptic elements (38). Each looped haptic element (38) is formed to have two broad connecting portions (40), two radial orientation portions (42), two spring portions (44) and a linking portion (46) for supporting the optic portion (34) in a patient's eye (10). The two broad connecting portions (40) of each looped haptic element (38) is permanently connected to the outer peripheral edge (36) of the optic portion (34). Each looped haptic element (38) is likewise formed to have greater resistance to bending in a plane generally parallel to an eye's optical axis than in a plane generally perpendicular to the eye's optical axis. The intraocular lens (32) is so designed to exhibit less than approximately 1.0 mm axial displacement or tilting of the optic portion (34) along the eye's optical axis under a compression force suitable to effect a 1.0 mm in diameter compression in overall length of the intraocular lens (32).

Description

INTRAOCULAR LENSES
FIELD OF THE INVENTION
The present invention relates to intraocular lenses (lOLs) and a
method for making and using the same. More particularly, the present
invention relates to lOLs designed primarily for refractive correction in aphakic
eyes. lOLs made in accordance with the present invention are used in
aphakic eyes to replace a surgically removed diseased natural lens, such as
in the case of cataracts.
BACKGROUND OF THE INVENTION
IOL implants have been used for years in aphakic eyes as
replacements for diseased natural crystalline lenses that have been surgically
removed from the eyes. Many different IOL designs have been developed
over past years and proven successful for use in aphakic eyes. The
successful IOL designs to date primarily include an optic portion with supports
therefor, called haptics, connected to and surrounding at least part of the
optic portion. The haptic portions of an IOL are designed to support the optic
portion of the IOL in the lens capsule, anterior chamber or posterior chamber
of an eye. Commercially successful lOLs have been made from a variety of
biocompatible materials, ranging from more rigid materials such as
polymethylmethacrylate (PMMA) to softer, more flexible materials capable of
being folded or compressed such as silicones, certain acrylics, and hydrogels.
Haptic portions of the lOLs have been formed separately from the optic
portion and later connected thereto through processes such as heat, physical
staking and/or chemical bonding. Haptics have also been formed as an
integral part of the optic portion in what is commonly referred to as "single-
piece" lOLs.
Softer, more flexible lOLs have gained in popularity in more recent
years due to their ability to be compressed, folded, rolled or otherwise
deformed. Such softer lOLs may be deformed prior to insertion thereof
through an incision in the cornea of an eye. Following insertion of the IOL in
an eye, the IOL returns to its original pre-deformed shape due to the memory
characteristics of the soft material. Softer, more flexible lOLs as just
described may be implanted into an eye through an incision that is much
smaller, i.e., 2.8 to 3.2 mm, than that necessary for more rigid lOLs, i.e., 4.8
to 6.0 mm. A larger incision is necessary for more rigid lOLs because the
lens must be inserted through an incision in the cornea slightly larger than the
diameter of the inflexible IOL optic portion. Accordingly, more rigid lOLs have
become less popular in the market since larger incisions have been found to be associated with an increased incidence of postoperative complications,
such as induced astigmatism.
After IOL implantation, both softer and more rigid lOLs are subject to
compressive forces exerted on the outer edges thereof, which typically occur
when an individual squints or rubs the eye. These compressive forces may
result in decentration of the IOL and distortion of the visual image.
Compressive forces exerted on an IOL also tend to cause the lens to tilt or
have axial displacement of the IOL along the optical axis of an eye.
Movement of an IOL along the optical axis of an eye has the potential to
cause the IOL to contact and damage delicate eye tissues. Also, lOLs of
current designs, whether formed of either softer or more rigid materials, tend
to deflect along the optical axis of an eye when the haptics are compressed.
IOL manufacturers provide a wide range of IOL sizes to more precisely fit
lOLs to each particular patient's eye size. Providing a wide range of IOL
sizes is an attempt to minimize the potential for axial displacement of the IOL
along the optical axis of an eye.
Because of the noted shortcomings of current IOL designs, there is a
need for lOLs designed to minimize tilt or axial displacement of the IOL optic
portion along the optical axis of the eye when compressive forces are exerted
against the outer edges thereof. By lessening an lOL's movement along the
optical axis of an eye, more certain refractive correction may be achieved and
the risk of tissue damage may be reduced. SUMMARY OF THE INVENTION
An intraocular lens (IOL) made in accordance with the present
invention has an optic portion with an outer peripheral edge and two looped
haptic elements for supporting the optic portion in a patient's eye. The
subject IOL is balanced having one looped haptic element formed on one
edge of the optic and the other looped haptic element formed on an opposed
edge of the optic. Each of the looped haptic elements has two broad
connecting portions, two radial orientation portions, two spring portions and a
linking portion connecting the two spring portions. The two broad connecting
portions of each looped haptic element are connected to the outer peripheral
edge of the optic portion. Each looped haptic element forms a large
fenestration to enhance capsular fixation once within an eye. The looped
haptic elements' spring portions and linking portions are designed to engage
an inner surface of a patient's eye.
Each looped haptic element's broad connecting portions are designed
to achieve optimal optic stability by avoiding tilt and axial displacement.
Within these broad connecting portions, each looped haptic element is
designed to bend in a plane generally perpendicular to the optical axis of an
eye rather than in a plane generally parallel to the optical axis of an eye. By
providing looped haptic elements with this type of flexibility characteristic, the
present IOL tends to have maximized stability within an eye. The flexibility characteristic of the subject looped haptic elements relative to the optic
portion eliminates unacceptable tilting or axial displacement of the optic
portion along the optical axis when compressive forces are exerted against
the looped haptic elements of the IOL.
Accordingly, it is an object of the present invention to provide
intraocular lenses for use in aphakic eyes.
Another object of the present invention is to provide intraocular lenses
for use in aphakic eyes with flexibility characteristics which maximize stability
thereof.
Another object of the present invention is to provide intraocular lenses
for use in aphakic eyes, which minimize tilt or axial displacement of the optic
portions of the lenses along the optical axis of the eyes.
Another object of the present invention is to provide intraocular lenses
for use in aphakic eyes, which minimize damage to tissues in the interior of
the eyes.
Still another object of the present invention is to provide intraocular
lenses, which are resistant to decentration within the eyes.
These and other objectives and advantages of the present invention,
some of which are specifically described and others that are not, will become
apparent from the detailed description, drawings and claims that follow,
wherein like features are designated by like numerals. BRIEF DESCRIPTION OF THE DRAWINGS
FIGURE 1 is a schematic representation of the interior of a human eye
including a natural lens;
FIGURE 2 is a plan view of an IOL with an optic and two looped haptic
elements made in accordance with the present invention;
FIGURE 3 is a side view of the IOL of Figure 2;
FIGURE 4 is a side view of the IOL of Figure 2 with sharper peripheral
edges on a posterior surface of the optic;
FIGURE 5 is a side view of the IOL of Figure 2 with sharper edges on
the two looped haptic elements;
FIGURE 6 is a side view of the IOL of Figure 2 with rounder edges on
the two looped haptic elements; and
FIGURE 7 is a side view of a looped haptic element of Figure 2 taken
along line 7-7 with a stiffening element therein.
DETAILED DESCRIPTION OF THE INVENTION
Figure 1 illustrates a simplified diagram of an eye 10 showing landmark
structures relevant to the implantation of an intraocular lens of the present
invention. Eye 10 includes an optically clear cornea 12 and an iris 14. A
natural crystalline lens 16 and a retina 18 are located behind the iris 14 of eye
10. Eye 10 also includes anterior chamber 20 located in front of iris 14 and
posterior chamber 22 located between iris 14 and natural lens 16. lOLs of the present invention are preferably implanted into lens capsule 24 or
posterior chamber 22 to refract light after a diseased natural lens 16 has been
surgically removed (aphakic application). Eye 10 also includes an optical
axis OA-OA that is an imaginary line that passes through the optical center 26
of anterior surface 28 and posterior surface 30 of lens 16. Optical axis OA-
OA in the human eye 10 is generally perpendicular to a portion of cornea 12,
natural lens 16 and retina 18.
The IOL of the present invention, as best illustrated in Figures 2 and 3,
is identified by reference numeral 32. IOL 32 is designed for implantation
preferably in lens capsule 24 or posterior chamber 22 of a patient's aphakic
eye 10. IOL 32 has an optic portion 34 with an outer peripheral edge 36.
Preferably integrally formed on peripheral edge 36 of optic portion 34 are two
opposed looped haptic elements 38, each having two broad connecting
portions 40, two radial orientation portions 42, two spring portions 44 and a
linking portion 46. Broad connecting portions 40 are preferably integrally
formed with and permanently connected to outer peripheral edge 36 of optic
portion 34. Alternatively however, looped haptic elements 38 may be
attached to optic portion 34 by staking, chemical polymerization or other
methods known to those skilled in the art.
In accordance with the present invention, each looped haptic element
38 is designed to preferably engage inner surfaces 48 in lens capsule 24 or
surfaces 50 in posterior chamber 22. Looped haptic elements 38 are designed so that when IOL 32 is implanted in a patient's eye 10 and held in
place through compressive forces exerted by inner surfaces 48 or 50, looped
haptic elements 38 flex to accommodate the particular size of eye 10.
Looped haptic elements 38 are designed to be resistent to flexing and tilting
in a plane generally parallel to that of optical axis OA-OA of eye 10. By
designing this type of flexibility characteristic into looped haptic elements 38,
IOL 32 may be manufactured in one or a few standard sizes and be a suitable
fit for most sizes of patients' eyes 10. The flexibility characteristic of looped
haptic elements 38 also minimize axial displacement of optic portion 34 in a
direction along optical axis OA-OA of eye 10.
Broad connecting portions 40 of looped haptic elements 38 attach the
looped haptic elements 38 to optic portion 34 of IOL 32. The broad
connecting portions 40 are designed to be broad to increase rigidity and to
minimize axial displacement or tilting of IOL 32. Broad connecting portions 40
likewise prevent the snagging or catching of eye 10 structures such as the
rhexis 52 on optic 34. Each broad connecting portion 40 preferably measures
to equal 10 to 20 percent of the circumference of the optic portion 34.
Radial orientation portions 42 of looped haptic elements 38 have
interior surfaces 54 and exterior surfaces 56. Interior surfaces 54 and exterior
surfaces 56 are formed with an outward curve to increase the stability of IOL
32 when implanted in eye 10. Outer ends 58 of radial orientation portions 42
are of a significantly smaller width than that of radial orientation portions 42 at broad connecting portions 40 to minimize the surface area thereof. The
surface area of outer ends 58 is designed to be as small as possible to
minimize the lOL's 32 contact with the lens capsule's 24 equatorial
germination zone 60 thereby decreasing cellular growth and posterior
capsular opacification of IOL 32. The width of outer ends 58 is also designed
to be smaller than that of the thickness of looped haptic elements 38 to allow
for flexing of spring portions 44 in a plane perpendicular to optical axis OA-OA
of eye 10.
Spring portions 44 have an interior surface 62 and an exterior surface
64. Spring portions 44 are designed to absorb compressive forces exerted by
the eye 10 and maintain IOL alignment within lens capsule 24. Spring
portions 44 when compressed upon absorption of compressive forces deform
whereby interior surfaces 62 may abut outer ends 58. Also, when placed
under sufficient compressive forces, each spring portion 44 may deflect
outwardly in a direction away from its adjacent spring portion 44 and
downwardly in a direction toward optic portion 34 to absorb such forces and
avoid undesirable flexing and tilting in a plane parallel to the optical axix OA-
OA of eye 10.
Linking portions 46 connect adjacent spring portions 44 to form a
looped haptic element 38. Linking portions 46 are slightly bowed at
preferably less than 20 degrees but more preferably at less than 10 degrees
but greater than 1 degree inwardly toward optic portion 34 to form depressions 66. Upon one or more spring portions 44 being deflected
outwardly in a direction away from its adjacent spring portion 44 and
downwardly in a direction of optic portion 34 when placed under compressive
forces, depression(s) 66 of linking portion(s) 46 looses its bow and becomes
more linear.
Fenestration 68 defined by interior surfaces 54 and 62, and interior
surfaces 70 of linking portion 46 enhances fixation of IOL 32 within lens
capsule 24 or posterior chamber 22.
Compressive forces of differing magnitudes within the range of
approximately 2 to 8 mN exerted against looped haptic elements 38 effecting
an approximately 2.0 mm in overall length compression of IOL 32, such as
that caused by differing eye sizes or compressive forces by the eye 10,
results in less than approximately 1.0 mm, but more preferably less than
approximately 0.5mm and most preferably less than approximately 0.3 mm
axial displacement or tilting of optic portion 34 along optical axis OA-OA in an
eye 10. Under like compressive forces, lOLs known in the art result in
approximately 2.0 mm axial displacement of the optic portion along the optical
axis in the eye, which may damage delicate tissues therein. The unique
design of IOL 32 achieves significantly minimized axial displacement or tilting
of optic portion 34 to protect the eye 10 from damage when compressive
forces are applied to eye 10. The flexibility characteristic of looped haptic elements 38 of IOL 32 as
described above is achieved through the unique design thereof. The exterior
surface 72 of linking portion 46 and the exterior surface 64 of spring portions
44 may be formed with either rounded edges 74 depicted in Figure 6 for a
smoother fit with inner surfaces 48 or 50, or more defined, sharper edges 76
depicted in Figure 5 to provide a barrier to prevent cellular migration and
growth. Another feature which may be incorporated into the subject lens is a
sharper peripheral edge 36 on posterior surface 35 of optic portion 34 as
depicted in Figure 4 to provide a barrier to prevent cellular migration and
growth.
The subject IOL 32 is preferably produced having an optic portion 34
approximately 4.5 to 9.0 mm, but preferably approximately 5.0 to 6.5 mm and
most preferably 5.5 mm in diameter and approximately 0.5 mm to 1.0 mm, but
preferably approximately 0.6 to 0.8 mm and most preferably 0.7 mm in
thickness at peripheral edge 36. Looped haptic elements 38 increase or
decrease in overall length depending upon the diameter of optic portion 34 so
that the overall length of IOL 32 remains generally consistent. As the
diameter of optic portion 34 increases, the overall length of looped haptic
elements 38 decrease. Likewise, as the diameter of optic portion 34
decreases, the overall length of looped haptic elements 38 increase. In
general, looped haptic elements 38 are formed to be approximately 8.5 to
13.5 mm, but preferably approximately 9.0 to 12.0 mm and most preferably approximately 10.5 mm in overall length. Such overall length is obtained
measuring from the center of broad connecting portion 40 around through the
center of looped haptic element 38 to the center of adjacent broad connecting
portion 40. The width of looped haptic elements 38 measuring the distance
between the outer tips 80 of spring portions 44 is approximately 4.5 to 9.0
mm, but preferably approximately 5.0 to 6.5 mm and most preferably 5.5 mm.
Looped haptic elements 38 have the same thickness thoughout their entire
length which is approximately 0.2 to 0.9 mm, but preferably approximately 0.3
to 0.7 mm and most preferably approximately 0.55 mm. Spring portions 44
measuring the distance from outer end 58 to exterior surface 64 at linking
portion 46 are approximately 0.4 to 1.5 mm, but preferably approximately 0.6
to 1.2 mm and most preferably approximately 0.8 mm. Radial orientation
portions 42 are approximately 1.6 to 4.5 mm, but preferably approximately 2.0
to 4.0 mm and most preferably approximately 3.0 mm in length measuring
from the center of broad connecting portion 40 to the center of outer end 58.
The desired flexibility characteristic of looped haptic elements 38 of
IOL 32 may likewise be achieved or enhanced by incorporating a stiffening
element 82, in the shape of a ribbon, in looped haptic elements 38, as
illustrated in Figure 7. Stiffening elements 82 may be positioned in looped
haptic elements 38 to function in a manner similar to that of an I-beam in
construction to prevent axial displacement or tilting along optical axis OA-OA
when compressive force is applied to looped haptic elements 38. Stiffening elements 82 are formed of a less flexible material than that
of IOL 32. Suitable materials for stiffening elements 82 include but are not
limited to polyimides, polyolefins, high-density polyethylenes, polyesters,
nylons, metals or any biocompatible material with suitable stiffening
characteristics. Stiffening elements 82 may be used in conjunction with
looped haptic elements 38 as described above or in cases where a thinner
looped haptic design is desired while still achieving the desired flexibility
characteristics.
Suitable materials for the production of the subject IOL 32 include but
are not limited to foldable or compressible materials, such as silicone
polymers, hydrocarbon and fluorocarbon polymers, hydrogels, soft acrylic
polymers, polyesters, polyamides, polyurethane, silicone polymers with
hydrophilic monomer units, fluorine-containing polysiloxane elastomers and
combinations thereof. The preferred material for the production of IOL 32 of
the present invention is a hydrogel made from 2-hydroxyethyl methacrylate
(HEMA) and 6-hydroxyhexyl methacrylate (HOHEXMA), i.e., poly(HEMA-co-
HOHEXMA). Poly(HEMA-co-HOHEXMA) is the preferred material for the
manufacture of IOL 32 due to its equilibrium water content of approximately
18 percent by weight, and high refractive index of approximately 1.474, which
is greater than that of the aqueous humor of the eye, i.e., 1.33. A high
refractive index is a desirable feature in the production of lOLs to impart high
optical power with a minimum of optic thickness. By using a material with a high refractive index, visual acuity deficiencies may be corrected using a
thinner IOL. Poly(HEMA-co-HOHEXMA) is also a desirable material in the
production of lOLs 32 due to its mechanical strength, which is suitable to
withstand considerable physical manipulation. Poly(HEMA-co-HOHEXMA)
also has desirable memory properties suitable for IOL use. lOLs
manufactured from a material possessing good memory properties such as
those of poly(HEMA-co-HOHEXMA) unfold in a controlled manner in an eye,
rather than explosively, to its predetermined shape. Explosive unfolding of
lOLs is undesirable due to potential damage to delicate tissues within the eye.
Poly(HEMA-co-HOHEXMA) also has dimensional stability in the eye.
Although the teachings of the present invention are preferably applied
to soft or foldable lOLs formed of a foldable or compressible material, the
same may also be applied to harder, less flexible lenses formed of a relatively
rigid material such as polymethyl methacrylate (PMMA) having flexible haptics
formed either of the same or a different material.
Optic portion 34 of IOL 32 can be a positive powered lens from 0 to
approximately +40 diopters or a negative powered lens from 0 to
approximately -30 diopters. Optic portion 34 may be biconvex, plano¬
convex, plano-concave, biconcave or concave-convex (meniscus), depending
upon the power required to achieve the appropriate central and peripheral
thickness for efficient handling. Optic portion 34 of the subject IOL 32 may optionally be formed with a
glare reduction zone 84 of approximately 0.25 to 0.75 mm but more
preferably approximately 0.3 to 0.6 mm and most preferably 0.5 mm in width
adjacent outer peripheral edge 36 for reducing glare when outer peripheral
edge 36 of IOL 32 is struck by light entering eye10 during high light or at
other times when pupil 86 is dilated. Glare reduction zone 84 is typically
fabricated of the same material as optic portion 34, but may be opaque,
colored or patterned in a conventional manner to block or diffuse light in plane
with optical axis OA-OA.
Subject IOL 32 is preferably manufactured by first producing discs from
a material of choice as described in U.S. Patent Nos. 5,217,491 and
5,326,506 each incorporated herein in its entirety by reference. IOL 32 may
then be machined from the material discs in a conventional manner. Once
machined, IOL 32 may be polished, cleaned, sterilized and packaged by a
conventional method known to those skilled in the art.
Subject IOL 32 is used in eye 10 by creating an incision in cornea 12,
inserting IOL 32 in posterior chamber 22 and closing the incision.
Alternatively, IOL 32 may be used in eye 10 by creating an incision in cornea
12 and lens capsule 24, removing natural lens 16, inserting IOL 32 in lens
capsule 24 and closing the incision.
IOL 32 of the present invention provides for a refractive lens suitable
for use in lens capsule 24 or posterior chamber 22. IOL 32 has looped haptic elements 38 with flexibility characteristics that minimize axial displacement or
tilting along optical axis OA-OA of eye 10 thereby preventing decentration of
IOL 32, distortion of vision and damage to delicate tissues within eye 10. IOL
32, having the flexibility characteristics described herein is also advantageous
because one or a few lens sizes suitably fit eyes 10 of most sizes. By
providing a "universal" lens such as that of the present invention, clinical risks
to patients due to improperly sized lenses are minimized. Such clinical risks
minimized include pupil ovalization, corneal endothelium damage and poor
fixation. Likewise, manufacturers' need to produce lOLs of many sizes to fit
eyes of many sizes is eliminated, thus reducing production and inventory
costs associated therewith. Ophthalmologists also benefit from subject IOL
32 in that time is saved by eliminating the need to determine each patient's
eye size and costs associated with maintaining large inventories of varying
sized lenses.
While there is shown and described herein certain specific
embodiments of the present invention, it will be manifest to those skilled in the
art that various modifications may be made without departing from the spirit
and scope of the underlying inventive concept and that the same is not limited
to the particular forms herein shown and described except insofar as
indicated by the scope of the appended claims.

Claims

We claim:
1. An intraocular lens to be implanted within an eye generally
perpendicular to the eye's optical axis comprising:
an outer peripheral edge defining an optic portion, and
two looped haptic elements permanently connected to the outer
peripheral edge,
whereby a compressive force sufficient to effect a 1.0 mm in
diameter compression of said lens results in less than
approximately 1.0 mm of axial displacement of said optic portion
along the eye's optical axis.
2. An intraocular lens to be implanted within an eye generally
perpendicular to the eye's optical axis comprising:
an outer peripheral edge defining an optic portion, and
two looped haptic elements permanently connected to the outer
peripheral edge,
whereby a compressive force sufficient to effect a 1.0 mm in
diameter compression of said lens results in less than
approximately 0.5 mm of axial displacement of said optic portion
along the eye's optical axis.
3. An intraocular lens to be implanted within an eye generally
perpendicular to the eye's optical axis comprising:
an outer peripheral edge defining an optic portion, and
two looped haptic elements permanently connected to the outer
peripheral edge,
whereby a compressive force sufficient to effect a 1.0 mm in
diameter compression of said lens results in less than
approximately 0.3 mm of axial displacement of said optic portion
along the eye's optical axis.
4. The intraocular lens of claim 1 , 2 or 3 wherein the looped
haptic elements and the optic portion are both formed of a foldable
or compressible material.
5. The intraocular lens of claim 1 , 2 or 3 wherein said lens is
formed from a material selected from the group consisting of
silicone polymers, hydrocarbon and fluorocarbon polymers,
hydrogels, soft acrylic polymers, polyester, polyamides,
polyurethane, silicone polymers with hydrophilic monomer units, fluorine-containing polysiloxane elastomers and combinations
thereof.
6. The intraocular lens of claim 1 , 2 or 3 wherein said lens is
formed from a hydrogel material.
7. The intraocular lens of claim 1 , 2 or 3 wherein said lens is
formed from a hydrogel material which is 18 percent by weight
water.
8. The intraocular lens of claim 1 , 2 or 3 wherein said lens is
formed from poly(HEMA-co-HOHEXMA).
9. The intraocular lens of claim 1 , 2 or 3 wherein said lens is
formed from a material having a refractive index above 1.33.
10. The intraocular lens of claim 1 , 2 or 3 wherein said lens is
formed from an acrylic material.
11. The intraocular lens of claim 1 , 2 or 3 wherein said lens is
formed from a silicone material.
12. The intraocular lens of claim 1 , 2 or 3 wherein said looped
haptic elements are dimensioned to have a greater thickness in a
plane generally perpendicular to the eye's optical axis than in a
plane generally parallel to the eye's optical axis.
13. The intraocular lens of claim 1 , 2 or 3 wherein a glare
reduction zone is formed adjacent to the outer peripheral edge of
the optic portion.
14. The intraocular lens of claim 1 , 2 or 3 wherein said looped
haptic elements include a stiffening element having a greater
resistance to bending in a plane generally parallel to an eye's
optical axis than in a plane generally perpendicular to the eye's
optical axis.
15. The intraocular lens of claim 1 , 2 or 3 wherein the looped
haptic element includes a stiffening element formed from a material
selected from the group consisting of polyimide, polyolefin, high-
density polyester, nylon and metal.
16. A method of manufacturing the intraocular lens of claim 1 , 2
or 3 comprising: forming a disk of a suitable material, and
machining said lens from said disk.
17. A method of using the intraocular lens of claim 1 , 2 or 3
comprising:
creating an incision in a cornea of an eye, and
inserting said intraocular lens in a posterior chamber of said
eye.
18. A method of using the intraocular lens of claim 1 ,2 or 3
comprising :
creating an incision in a cornea and lens capsule of an eye,
removing a natural lens of said eye, and
inserting said intraocular lens in said lens capsule of said eye.
PCT/US2000/007698 1999-04-29 2000-03-23 Intraocular lenses WO2000066041A1 (en)

Priority Applications (7)

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BR0011218A BR0011218A (en) 1999-04-29 2000-03-23 Intraocular lenses
CA 2370859 CA2370859C (en) 1999-04-29 2000-03-23 Intraocular lenses
AU39124/00A AU775571B2 (en) 1999-04-29 2000-03-23 Intraocular lenses
JP2000614928A JP2002542885A (en) 1999-04-29 2000-03-23 Intraocular lens
MXPA01010983A MXPA01010983A (en) 1999-04-29 2000-03-23 Intraocular lenses.
EP00918291A EP1173114A1 (en) 1999-04-29 2000-03-23 Intraocular lenses
HK02105266.4A HK1045248A1 (en) 1999-04-29 2002-07-16 Intraocular lenses

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US09/301,883 1999-04-29
US09/301,883 US6200344B1 (en) 1999-04-29 1999-04-29 Inraocular lenses

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US (1) US6200344B1 (en)
EP (1) EP1173114A1 (en)
JP (1) JP2002542885A (en)
AR (1) AR029357A1 (en)
AU (1) AU775571B2 (en)
BR (1) BR0011218A (en)
CA (1) CA2370859C (en)
HK (1) HK1045248A1 (en)
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CA2370859A1 (en) 2000-11-09
BR0011218A (en) 2002-03-19
HK1045248A1 (en) 2002-11-22
EP1173114A1 (en) 2002-01-23
US6200344B1 (en) 2001-03-13
AU3912400A (en) 2000-11-17
AR029357A1 (en) 2003-06-25
JP2002542885A (en) 2002-12-17
CA2370859C (en) 2005-09-13
AU775571B2 (en) 2004-08-05
MXPA01010983A (en) 2003-10-14

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